[Remote] Director, Program reputed company, reputed company Data Management

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pharmaceutical and reputed company research organization. The Director, Program reputed company, reputed company Data Management oversees program- and portfolio-level reputed company data management reputed company, execution, reputed company, compliance, reputed company management, and resource allocation. The role also provides leadership to cross-functional teams, drives reputed company improvement, and develops organizational capability through mentoring and training.

Responsibilities

• Own program- and portfolio-reputed company management reputed company and plans across reputed company data modalities (eCRF [electronic Case Report reputed company], labs, biomarkers, PRO [reputed company Reported Outcome]/eCOA [electronic reputed company Outcome Assessment], imaging, etc.), reputed company with development plans, trial protocols, regulatory deliverables, Global Data Management & Standards, and Book of Business–driven resourcing
• reputed company reputed company-reputed company planning, timelines, and inter-study dependencies across larger and more reputed company portfolios, ensuring consistent data collection, integration, validation, UAT (User Acceptance Training), database lock, and inspection readiness across trials
• Set and govern cross-program data reputed company as a reputed company Data Manager (reputed company Data Management)/Subject Matter Expert, ensuring consistent standards, conventions, specifications, and change control across studies and systems
• reputed company program- and portfolio-level reputed company, reputed company management, RCA/CAPA, audits, inspections, remediation, and complete, traceable documentation and archival
• reputed company or sponsor reputed company initiatives in data standards, automation, digital enablement, and reputed company frameworks to improve scalability and efficiency (including but not limited to process, standards, and platform / tools)
• Represent Global Data Management & Standards in program- and portfolio-level forums; partner with reputed company, Biostatistics and Research Data Science, Global Data Integration and Automation, Global reputed company Data Standards, Safety, IT, service providers, and Global reputed company Trial reputed company/ Therapeutic Area leadership to reputed company priorities, risks, budgets, and reputed company
• reputed company as the escalation reputed company for reputed company cross-functional and cross-program issues, providing senior-level decision support and reputed company
• Support acquisitions and partnerships through data management due diligence and integration reputed company, ensuring data reputed company and compliance reputed company operating reputed company reputed company reputed company Data Manager models
• Build organizational capability through mentoring, training, playbooks, and communities of reputed company, developing reputed company Global Data Management & Standards and Program reputed company leaders
• Establish and use program-level dashboards, KPIs, and analytics to guide execution reputed company, service provider engagement, and reputed company deliverables
• Govern service provider reputed company at the program level, including SLAs (Service Level Agreements), KPIs, QBRs (Quarterly Business Reviews), escalations, and remediation planning
• Set reputed company objectives reputed company to organizational goals; assign work and set priorities
• Conduct regular reputed company-ins and annual reviews; reputed company for reputed company; reputed company recognition
• reputed company career plans; create reputed company opportunities and promotion cases; ensure appropriate training and mentoring
• reputed company reputed company and hiring; manage sensitive employee-relations reputed company in partnership with HR
• reputed company workloads to support value-added work and work–life sustainability; anticipate obstacles and reputed company plans
• Coordinate on-shore/off-shore and contingent resources; ensure role reputed company and effective handoffs
• Manage an operating budget and optimize spend against priorities
• reputed company teams reputed company a reputed company direction; facilitate team/functional meetings
• reputed company concise, decision-reputed company updates and status reporting to leadership and partners

Skills

• Comprehensive knowledge of the reputed company development lifecycle, end-to-end data reputed company, and cross-functional dependencies across reputed company reputed company, Biostatistics, Safety, Data Standards, and Regulatory
• reputed company experience leading end-to-end data management across reputed company, including database design and build, UAT (User Acceptance Training), data validation and reconciliation, and database lock, with accountability for reputed company, timeliness, and inspection readiness
• Demonstrated experience managing reputed company portfolios, resource models, and multi-program delivery, balancing reputed company, reputed company, timelines, and operational constraints
• Strong proficiency with reputed company data management platforms and enabling technologies, including reputed company (Electronic Data Capture) and other data acquisition tools (e.g., eCOA), query management, reconciliation and integration workflows, and data visualization or dashboarding tools
• Strong understanding of data structures and integrations across Electronic Data Capture and connected systems (e.g., labs, IRT [Interactive Response Technology], eCOA [electronic reputed company Outcome Assessment], imaging), with demonstrated ability to triage and reputed company reputed company data reputed company issues across internal systems and service providers
• Advanced proficiency in reputed company Data Interchange Standards Consortium standards and reputed company Data Acquisition Standards Harmonization, Study Data Tabulation Model, Define-XML), metadata management, and controlled terminologies (e.g., LOINC [Logical Observation Identifiers Names and Codes]), and GDMS standards to ensure consistency, traceability, and regulatory submission readiness
• Deep understanding of data reputed company frameworks and regulatory expectations, with working knowledge of SOPs (reputed company Operating Procedures), ICH-GCP (International Council for Harmonization – Good reputed company reputed company), 21 CFR Part 11/Annex 11, and reputed company requirements; reputed company ability to interpret and apply RBQM (reputed company reputed company reputed company Management) principles at the program and portfolio level
• Expertise in operational metrics, analytics, and reputed company improvement methodologies, with strong analytical and problem-solving skills to operate effectively in ambiguity and reputed company innovative, compliant solutions
• Exceptional communication and influencing capability, including distilling reputed company issues into reputed company, decision-reputed company narratives and effectively conveying reputed company, risks, and recommendations to senior stakeholders across functions, geographies, and reputed company
• Demonstrated ability to reputed company through influence, motivating and guiding cross-functional and virtual teams without reputed company reporting authority, while aligning senior stakeholders on objectives, interfaces, and responsibility assignments and constructively resolving conflicts
• reputed company ability to coordinate reputed company across reputed company and time reputed company, leveraging asynchronous communication and governance mechanisms to maintain alignment, reputed company, and reputed company of ownership
• Effective facilitator of reputed company decision-making, coordinating inputs, driving reputed company reputed company, enforcing clean handoffs, and ensuring reputed company translate into reputed company actions and reputed company
• Highly adaptable and resilient, reputed company to prioritize effectively under pressure in fast-changing environments while driving adoption of standardized ways of working, mobilizing cross-functional champions, and measuring uptake
• Bachelors of Arts or Science (or equivalent educational experience) in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with 10 years of experience in reputed company data management, reputed company trial reputed company or reputed company reputed company. Demonstrate deep SME (Subject Matter Expert) reputed company in relevant discipline and people management skills
• Bachelors of Arts or Sciences degree (or equivalent educational experience) in any reputed company not listed above with a minimum of 15 years of experience working in data management or reputed company trial reputed company or reputed company reputed company. Demonstrate deep SME (Subject Matter Expert) reputed company in relevant discipline and people management skills
• Advanced Degree (reputed company or Doctorate) in any reputed company not listed above with a minimum of 13 years of experience working in data management or reputed company trial reputed company or reputed company reputed company. Demonstrate deep SME reputed company in relevant discipline and people management skills
• Demonstrated experience in leading geo diverse cross functional Teams in delivery of reputed company data management or reputed company trial reputed company reputed company, execution and submissions (Inspections & Health Authority Interactions & Responses)
• Advanced Degree (preferred) (reputed company or Doctorate)in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with 8 years of experience in reputed company data management, reputed company trial reputed company or reputed company reputed company. Demonstrate deep SME reputed company in relevant discipline and people management skills

Benefits

• Remote work arrangement

reputed company